FDA.reportPublic FDA data

0.8 ML adalimumab-aacf 50 MG/ML Injection

RxCUI
2699315
RxNorm name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Display name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Full name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2699315

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
08dbaffe-9d05-43cf-b24b-b44ade8685fcadalimumab-aacf 40 MG in 0.8 ML Injection [PSN] · 0.8 ML adalimumab-aacf 50 MG/ML Injection [SCD] · adalimumab-aacf 40 MG per 0.8 ML Injection [SY]31These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO . IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful 20241015